MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Model Number 5450-35-500

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Pain (1994); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Swelling/ Edema (4577)

Event Date 03/17/2020

Event Type  Death  

Event Description

Patient received a right primary attune to treat severe end-stage arthritis.The patella was resurfaced and depuy cement x 2 was utilized.The surgeon notes that the patient had a preexisting left bka that was performed to treat a clotting issue.The procedure was completed without complications.Patient received a right knee revision to treat pain, swelling, and inability to walk secondary to aseptic loosening.The patient has extensive comorbidities.Because of this, he was given dialysis and extensive treatments for his preexisting clotting disorder before being approved for the revision and cleared for the procedure.Upon entering the joint, scar tissue was debrided from the joint.The tibial tray was grossly loose and debonded at the cement to implant interface and easily removed.The femoral component and patella were both loose at an unknown interface and revised.There was no reported product problem with the revised tibial insert.The patient was revised with competitor products.The procedure was completed without complications.Hours after the revision.The patient had an episode of hypotension and confusion and was transferred to the icu.Dialysis was attempted but was discontinued as the hypotension returned.Ct scan revealed significant ischemic and dead bowel.The family and physicians conversed, and corrective surgery was declined.Patient was given comfort measures and expired on the second post-operative day.There is insufficient information provided to determine the root cause of the death and the depuy synthes products cased or contributed to the reported death two days after the revision.Doi: (b)(6) 2016, dor: (b)(6) 2020, dod: (b)(6) 2020, right knee.

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Added combination device information to h10: dmf# - (b)(4).Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device 545035500, and lot 8159147, no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13664732
• MDR Text Key: 286553807
• Report Number: 1818910-2022-04054
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2017
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 8159147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE PS FEM RT SZ 7 CEM.; ATTUNE PS RP INSRT SZ7 5MM.; ATTUNE RP TIB BASE SZ 6 CEM.; SMARTSET GHV GENTAMICIN 40G.
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Black Or African American